Following KEI request for investigation, Cold Spring Harbor Labs says 7 patents require correction to disclose federal funding

Summary:

  • After KEI filed a complaint with the NIH, Cold Spring Harbor Laboratory (CSHL) corrected a failure to disclose funding of at least 7 patented inventions, including one patent for the drug Sprinraza.
  • Since 2012, when federal funding was relevant to an invention, CSHL failed to make a disclosure on a filed patent more than half the time.

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Penn “Certificates of Correction” on Federal Funding for 5 CAR T Patents

On October 17, 2017, KEI sent a letter to the NIH regarding the failure of the University of Pennsylvania to disclose federal funding of five patented inventions for CAR T.

Today (October 18, 2017), we received this statement from the University:

“We have reviewed the letter and have confirmed that each of these patents was reported to the government as having NIH funding.

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WIPO General Assembly 2017: KEI statement on the Standing Committee on the Law of Patents (SCP)

On Wednesday, 4 October 2017, Knowledge Ecology International (KEI) delivered the following statement at the WIPO General Assembly during discussions on the Report of the Standing Committee on the Law of Patents (SCP).

WIPO General Assembly 2017 – Statement of KEI on the Report on the Standing Committee on the Law of Patents (SCP)

4 October 2017

Agenda item: 14. Report on the Standing Committee on the Law of Patents (SCP)

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KEI asks HHS to use Bayh-Dole rights in Zinbryta patent (drug for multiple sclerosis)

Attached is a letter sent on September 14, 2017 to Andrew Bremberg, an Assistant to the President and the Director of the Domestic Policy Council at the White House, and Keagan Lenihan, a Senior Adviser to HHS Secretary Tom Price, regarding Zinbrytra (INN: daclizumab), a drug to approved by the FDA to treat multiple sclerosis. (PDF version here)

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2017: Nanobernetics proposed exclusive license for NIH patents on Apparatus for Microarray Binding Sensors

(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) The attached file (copy here) is the KEI questions and initial comments on the Prospective Grant of an Exclusive Patent License: Apparatus for Microarray Binding Sensors Having… Continue Reading

2017: Kymriah, the Novartis $475,000 CAR T treatment, received 50 percent Orphan Drug tax credit on trials

Missing in the reporting on the Novartis price for Kymriah, its new $475,000 CAR T treatment, is that Novartis received an Orphan Drug designation in February 3, 2015, and sequently received a tax credit subsidy from the United States equal to 50 percent of the cost of qualifying clinical trials.

From the FDA database on Orphan Designations:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=463114

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KEI statement regarding Gilead’s Acquisition of Kite Pharma

KEI statement regarding Gilead’s Acquisition of Kite Pharma.

“Congress should require the NIH to enforce the Bayh-Dole obligation to make the Kite Pharma Chimeric Antigen Receptors Technologies (CAR T) treatments available to the public on reasonable terms.

KEI notes that Kite reported spending $317 million in R&D from 2012 to June 30, 2017, and is selling the company for $11.9 billion.

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Workshop: Patents, the Public Interest and Two New Medical Technologies: CRISPR and CAR T

Workshop: Patents, the Public Interest and Two New Medical Technologies: Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), Chimeric Antigen Receptors (CAR) technologies

On September 15th, 2017, Knowledge Ecology International will be hosting a workshop on: “Patents, the Public Interest and Two New Medical Technologies: CRISPR and CAR T.”

If you are unable to attend in person, a livestream of the event will be available here

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2017: Salubris Biotherapuetics: Bispecific, Biparatopic Antibody-Drug Conjugate for Human Liver Cancers

(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) Attached are the August 8, 2017 KEI comments regarding the prospective grant of an exclusive patent license by the NIH to Salubris Biotherapuetics for the development of… Continue Reading